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NCT01271998 Clinical Trial

Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg

Bacterial Infection Clinical Trial

Official title:
Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg TR-701 Free Acid in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01271998
Other study ID # 1986-027
Secondary ID TR701-119
Status Completed
Phase Phase 1
First received
Last updated
Start date December 8, 2010
Est. completion date January 3, 2011

Study information
Verified date November 2019
Source Trius Therapeutics LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of this study is to determine the steady-state plasma pharmacokinetics (PK) and properties of TR-700 into the pulmonary epithelial lining fluid (ELF) and alveolar macrophages (AM) of healthy volunteers.

Description:

No applicable.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date January 3, 2011
Est. primary completion date January 3, 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Healthy males and females, between 18 and 55 years of age, inclusive

- Females must be nonpregnant, nonlactating, and either postmenopausal or surgically sterile or practicing an effective method of birth control

- Males must be surgically sterile, abstinent, or practicing an effective method of birth control

- BMI between 20 and 34.9 kg/m2, inclusive

Exclusion Criteria:

- Allergy to lidocaine, midazolam, or other anesthetics/sedatives of similar classes

- Physician-diagnosed migraine headaches within 3 years

- Previous enrollment in a TR-701 or TR-701 FA trial

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• TR-701 FA
200 mg, oral, once daily for 3 days.

Locations
Country Name City State
United States Trius Investigator Site 001 Hartford Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Trius Therapeutics LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

Housman ST, Pope JS, Russomanno J, Salerno E, Shore E, Kuti JL, Nicolau DP. Pulmonary disposition of tedizolid following administration of once-daily oral 200-milligram tedizolid phosphate in healthy adult volunteers. Antimicrob Agents Chemother. 2012 May — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetic parameters from plasma. Pharmacokinetic parameters compared with baseline measurements. Day 3
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